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| Product NDC Code | 51326-122 | ||||
|---|---|---|---|---|---|
| Drug Name | Essential moisturizing sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Topiderm, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Zinc Oxide 14.8% Sunscreen Octinoxate 7.5% Sunscreen
| Zinc Oxide 14.8% | Sunscreen |
| Octinoxate 7.5% | Sunscreen |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply liberally to face and neck and spread evenly 15 minutes before sun exposure Re-apply after swimming, excessive perspiring, or anytime after towel drying Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Purified Water, Diethylhexyl Succinate, Octyldodecyl Neopentanoate, Cetearyl Glucoside, Cetyl Ethylhexanoate, Polyisobutene, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Xanthan Gum, Butylene Glycol, Triethoxycaprylylsilane, Oleth-3 Phosphate, Ethylhexyl Stearate, Dimethicone, Sucrose, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-7 Trimethylolpropane Coconut Ether, Panthenol, Phenoxyethanol, Disodium EDTA.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Zinc Oxide 14.8% Sunscreen Octinoxate 7.5% Sunscreen
| Zinc Oxide 14.8% | Sunscreen |
| Octinoxate 7.5% | Sunscreen |
Spl product data elements
Usually a list of ingredients in a drug product.Essential Moisturizing Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE OCTINOXATE OCTINOXATE WATER DIETHYLHEXYL SUCCINATE OCTYLDODECYL NEOPENTANOATE CETEARYL GLUCOSIDE CETYL ETHYLHEXANOATE POLYISOBUTYLENE (2300 MW) HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE CAFFEINE XANTHAN GUM 1,3-BUTANEDITHIOL TRIETHOXYCAPRYLYLSILANE OLETH-3 PHOSPHATE ETHYLHEXYL STEARATE DIMETHICONE SUCROSE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER PANTHENOL PHENOXYETHANOL EDETATE DISODIUM
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 63 g Bottle Label REPLENiX ® SUNSCREEN ESSENTIAL MOISTURIZING SPF 50 14.8% Micronized Zinc Oxide Hydrating Hyaluronic Acid Quick-absorbing Application BROAD SPECTRUM UVA/UVB SPF 50 Net wt. 2.22 oz. (63 g) TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701 PRINCIPAL DISPLAY PANEL - 63 g Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sunscreen measures including: limit time in the sun, especially from 10 a.m.-2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product keep out of eyes, rinse with water to remove.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API